Mint Medical GmbH: mint Lesion, Software Versions: 3.10.0 and 3.10.1.

Hazard

Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images.

Details from the source

Reason for recall: Some software versions have a malfunction where they may show incorrect orientation labels for a specific subset of DICOM images. Distribution: Worldwide distribution: US (nationwide): AR, CA, FL, GA, MI, MN, NY, OH, PA, TN, TX, WI; and OUS (International) to countries of: Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom. Quantity: 18 units (7 US, 11 OUS) Lot/code info: Software Versions: 3.10.0 and 3.10.1; UDI-DI: 04260495883106;

UPC codes

04260495883106

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.